16 results
·
23ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PICSI SPERM SELECTION DEVICE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)
FDA 510(k)
FDA Class 2
·Neurology
!NSURE FECAL OCCULT BLOOD TEST
FDA 510(k)
FDA Class 2
·Hematology
XPS® BUR - STYLUS TRANSNASAL
FDA Adverse Event
Malfunction
·MEDTRONIC XOMED INC.·Product code ERL·March 16, 2017
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·August 16, 2017
V-14¿ CONTROLWIRE®
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code DQX·April 11, 2013
ST104 TRANSPORT
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FPO·March 16, 2011
CC IRON/MAGNESIUM CALIBRATOR
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES, INC·Product code JIX·May 22, 2008
ARCHITECT ANTI-TPO
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 11, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·December 10, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·September 16, 2025
ARCHITECT ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT LABORATORIES·Product code JZO·May 23, 2025
ALINITY I ANTI-TPO REAGENT KIT
FDA Adverse Event
Malfunction
·ABBOTT IRELAND DIAGNOSTICS DIVISION·Product code JZO·March 17, 2025
Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204);
FDA 510(k)
FDA Class 2
·Dental
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012